Continuous Improvement & Performance Manager

Continuous Improvement & Performance Manager Location: Cambridge, MA About the job As Continuous Improvement & Performance (CIP) Manager within the R&D team, you will support the GRA business to continuously improve its ways of working using data and digital technology to be a highly performing and compliant business. You will be responsible for building strong and effective relationships with key business partners to understand their needs, catalyze an agile mindset, and champion the use of digital tools. In this role, you will serve as the Quality Document Manager (or Quality Document Expert) for GRA — the primary authority on Quality Documentation (QD) lifecycle management within the QualiPSO Content Management System (CMS). You will partner with Business Process Owners, Subject Matter Experts, and Global Quality networks to ensure GRA's documentation ecosystem is compliant, current, and continuously improving. Your work directly supports global regulatory compliance, patient safety, and the integrity of Sanofi's Quality Management System. Main Responsibilities Establish and maintain the GRA Quality Documentation Management System: lead the end‑to‑end management of GRA's Quality Documentation system within QualiPSO (CMS), ensuring full compliance with Global Quality (GQ) standards and Medical Clinical Country Quality (MCCQ) –specific requirements. Define, implement, and maintain the GRA QD System in alignment with GQ standards, MCCQ requirements, and applicable regulatory frameworks including 21 CFR Part 211 and GxP regulations. Manage the complete document lifecycle — including creation, revision, approval, distribution, periodic review, and obsolescence — in accordance with QualiPSO procedures. Oversee Document Change Request (DCR) management, ensuring changes driven by regulatory updates, process transformations, audit findings, or content improvements are processed accurately and on time. Execute and manage periodic review workflows, coordinating SME assessments and delivering verdicts (Keep Effective, Needs Revision, or Make Obsolete) in compliance with QualiPSO requirements. Administer workflow management and electronic signature procedures within QualiPSO CMS, ensuring proper routing, review, and approval by authorized personnel. Maintain and manage the annual Document Plan for GRA, covering new documents, upcoming periodic reviews, planned revisions, and documents scheduled for obsolescence. Provide expert guidance to ensure key regulatory activities and processes are documented and implemented in compliance with GxP regulations. Support and advise the Business Process Owner (BPO) network throughout the complete QD lifecycle, acting as a trusted subject matter expert. Ensure consistency across GRA, MCCQ, and GQ quality documents, adhering to the MOSAIC philosophy by eliminating redundancy and duplication. Communicate timely updates on new, revised, and obsolete QDs to internal and external GRA stakeholders. Manage GRA user access rights and permissions within QualiPSO CMS. Lead the QD Training Strategy for the GRA Population: design and drive a robust, fit‑for‑purpose training strategy that ensures GRA personnel are qualified and current on all applicable quality documents. Collaborate with BPOs, SMEs, and Excellence networks to define, maintain, and simplify Training Curricula content aligned with QD applicability. Partner with the GRA QD training team/Hub to implement the defined training strategy effectively and consistently. Document and maintain training requirements rationale with supporting evidence, ensuring traceability and audit‑readiness. Drive compliance and continuous improvement across GRA quality by applying a scientific, methodical, and documented approach to quality improvement, using data and risk management principles. Contribute to the resolution of audit findings and deviation CAPAs related to QDs, defining remediation actions and tracking their effectiveness. Identify, collect, and communicate opportunities for continuous improvement in QD processes, ensuring a follow‑up plan is associated with each initiative. Support the annual Quality review process, providing QD‑related metrics, trend analysis, and risk assessments. Apply quality risk management approaches to proactively identify documentation gaps and vulnerabilities before they impact compliance. Foster a culture of continuous improvement within GRA, encouraging teams to challenge the status quo and adopt best practices. Represent GRA Through Cross‑Functional Collaboration Serve as GRA's voice and advocate in global quality networks, ensuring GRA's needs are understood and addressed at all levels. Serve as an active member of MCCQ (QD & Training networks) and Global Quality (Training CoPs, Doc Cluster) committees and projects. Coordinate transversal QD reviews across MCCQ and GQ, facilitating alignment and consistency. Facilitate and coordinate GRA SME requests for MCCQ processes, acting as the primary liaison. Leverage cross‑functional collaboration opportunities to drive innovation in documentation practices and share best practices across the broader Sanofi quality community. About you You are a detail‑oriented, collaborative, and forward‑thinking quality professional who combines deep technical expertise in document management with a passion for continuous improvement. You thrive in complex, matrixed environments and are energized by the opportunity to make a meaningful impact on global regulatory compliance and patient safety. Minimum Requirements Education: BS/BA degree in a relevant scientific discipline required. Experience: 5+ years of relevant experience, with at least 2+ years working in Regulatory Affairs (regionally or globally). Quality Systems: 2+ years of experience in GxP Quality system management, with demonstrated hands‑on experience managing Quality Documents through their full lifecycle. CMS Expertise: Advanced proficiency in Content Management Systems (CMS), with direct experience in both document controller and document creator roles within an electronic document management system (preferably Veeva). Regulatory Knowledge: Working knowledge of 21 CFR Part 211 and applicable GxP regulatory standards governing documentation and records management. Continuous Improvement: Demonstrated experience applying quality risk management approaches and continuous improvement methodologies in a regulated environment. Leadership & Interpersonal Skills Excellent time‑management and operational skills including planning, organizing, and the ability to motivate and influence others without direct authority. Strong sensitivity for a multicultural and multinational environment. Demonstrated ability to use appropriate interpersonal styles and techniques to build internal networks and lead negotiations with internal and external stakeholders in a highly matrixed structure. Ability to act as a change agent during times of transition and transformation, guiding teams through evolving quality requirements and digital tool adoption. Ability to operate with discretion and confidentiality about sensitive data. Communication & Analytical Skills Excellent oral and written communication skills — invaluable in communicating with global, cross‑functional, cross‑cultural, and multi‑disciplinary teams. Experienced in communicating vertically and horizontally within an organization with necessary cultural awareness and sensitivity. Strong analytical skills with the ability to analyze complex information, identify trends, and make data‑driven decisions to improve documentation processes and quality outcomes. Ability to rapidly understand and analyze complex problems/situations and actively lead and/or participate in the management of solution development and implementation. Technical & Quality Competencies Proficiency in electronic document management systems, particularly Veeva CMS, including document creator and document controller role functions. Strong project management skills for managing documentation projects, including timelines, resources, and deliverables. Solid knowledge of GxP compliance requirements and their application to quality documentation. Familiarity with document lifecycle management best practices, including DCR management, periodic review workflows, and electronic signature procedures. Benefits High‑quality healthcare, prevention and wellness programs. At least 14 weeks' gender‑neutral parental leave. Work‑life balance initiatives, including flexible work arrangements and health‑wellbeing benefits. Equal Opportunity & Diversity Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, natural or protective hairstyles, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status or liability for military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #J-18808-Ljbffr